Applying for a Drug Identification Number (DIN) to distribute or sell hand sanitizer: Eligible products

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Products eligible for monograph licensing stream

Hand sanitizers containing 1 of the following non-prescription drug medicinal ingredients, within the concentrations indicated below, are eligible for a DIN through the Category IV monograph (DINF) stream:

Products are not eligible for authorization under the monograph if they contain:

Non-medicinal ingredients

All non-medicinal ingredients (NMI) in the product must:

An NMI is any substance that is added to give suitable consistency or form to the medicinal ingredients (suitable as per dosage form and route of administration).

NMIs must be safe. They must not:

Monograph requirements

Monographs are developed for drugs with a well-characterized safety and efficacy profile under specific conditions of use. Therefore, evidence to support safety, efficacy, and quality of the product are not needed, as long as these products meet all parameters of the monograph:

Hand sanitizers must meet the quality requirements specified in the Food and Drug Regulations (FDR) for drugs. An attestation to the monograph also attests to the adherence to the Good Manufacturing Practices (GMP) requirement of the FDR.

Although you do not need to submit chemistry and manufacturing data to Health Canada, it is important to keep all pertinent information on file, including:

Note that the monograph includes claims only for personal domestic use. No additional claims outside the monograph are permitted, such as:

This monograph does not apply to:

For information on the filing requirements for products outside the monograph, please contact the NNHPD at hc.nnhpd-dpsnso.sc@canada.ca.

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